Neoadjuvant FDR GX in Locally Advanced Pancreatic Cancer
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
Summary
The rationale for phase II trial of neoadjuvant fixed dose rate gemcitabine plus capecitabine
for patients with LAPC includes the following: First, obtaining a sufficient tumor
down-staging to procure R0/R1 resection, reported to be one of the most significant
prognostic factors for survival; second, providing an observation period to exclude from
surgery those patients with rapidly progressive disease there by to help select patients for
surgery who have the greatest likelihood of a favorable postoperative outcome; third,
eliminating micrometastatic disease, that is likely present in most patients, earlier than
adjuvant setting and preventing post-surgical growth spurts; fourth, adjuvant therapy given
in the neoadjuvant setting is better tolerated, as the patient has not recently undergone a
major operation; and the last, the lack of widely accepted optimal preoperative or palliative
approach in patients with LAPC, the majority of whom may not be operated on.
The primary goal is to determine the R0 resection rate of the neoadjuvant fixed dose rate
(FDR) gemcitabine-capecitabine combination chemotherapy in patients with borderline
resectable or unresectable locally advanced pancreatic adenocarcinoma.
The secondary goals are to assess progression-free survival (PFS) and OS (overall survival)
in these patients and to assess adverse events of these neoadjuvant treatments.